Medicaid, Drug Pricing, Covered Entities

This Week in 340B: July 2 – 8, 2024

McDermott Will & Emery on 7/10/2024

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Government Continues to Explore Role of 340B Contract Pharmacies

Goodwin on 9/15/2023

The 340B Drug Pricing Program (the “Program”) allows certain healthcare providers (“covered entities”) to purchase pharmaceuticals from drug manufacturers at discounted rates. Some covered entities do not have an internal...more

This Week in 340B: August 2023 #2

McDermott Will & Emery on 8/22/2023

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

This Week in 340B: April 2023 #4

McDermott Will & Emery on 4/27/2023

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more

340B Drug Pricing Program Reform Considerations

Goodwin on 2/14/2023

The 340B Drug Pricing Program is a government program, administered by the Health Resources and Services Administration (HRSA), that allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy...more

Supreme Court Will Hear Several Health Care Cases in 2022 Term

Foley Hoag LLP - Medicaid and the Law on 7/20/2021

Recently, my colleague Regina DeSantis told you about the ongoing saga involving disputes between 340B contract pharmacies and pharmaceutical manufacturers. We often write about the 340B program on our blog because of the...more

340B in 2021: What Covered Entities and Their Partners Need to Know Now

McDermott Will & Emery on 3/31/2021

Since March 2010, increased growth in the 340B Program has been accompanied by increased scrutiny from state and federal governments and conflicts between various 340B Program stakeholders. A transition in U.S. Department of...more

[Webinar] 340B in 2021: What Covered Entities and Their Partners Need to Know Now - March 18th, 2:00 pm - 3:00 pm ET

McDermott Will & Emery on 3/16/2021

This must-attend webinar will give 340B covered entities and their partners up-to-the-minute insights into the most pressing issues affecting their business today and the trends that will shape the market tomorrow. Our...more

The 340B Contract Pharmacy Saga Continues

Foley Hoag LLP - Medicaid and the Law on 1/6/2021

Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more

340B Update: HRSA Moves Forward with 340B ADR Rule as Covered Entities Challenge Contract Pharmacy Actions

K&L Gates LLP on 12/3/2020

In this episode of Triage, Andrew Ruskin and Victoria Hamscho provide an update on recent developments in the 340B Program and, in particular, on two recent legal challenges covered entities brought in response to drug...more

The 340B Contract Pharmacy Saga

Foley Hoag LLP - Medicaid and the Law on 9/24/2020

We are back again with another 340B post. The 340B program has recently been a regular feature on the blog in the context of ongoing litigation discussed here and here. Today, we wanted to provide readers the details of an...more

OPA Program Update 2020 Highlights Changes to 340B Program Registration and Recertification Requirements

Hinshaw & Culbertson - Health Care on 8/18/2020

On July 20, 2020, the Health Resources and Services Administration's (HRSA) Office of Pharmacy Affairs (OPA) issued the OPA Program Update 2020. In addition to adopting new Covered Entity registration and recertification...more

K&L Gates Triage: 340B Update - Hospitals Request Eligibility Flexibilities Amid COVID-19 Pandemic

K&L Gates LLP on 4/9/2020

In this episode, Richard Church and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent COVID-19 guidance by the Health Resources and Services Administration and hospital requests...more

GAO Recommends CMS, HRSA Improve 340B Duplicate Discount Oversight

McDermott Will & Emery on 2/5/2020

On January 27, the Government Accountability Office (GAO) published a report concluding that the US Department of Health and Human Services (HHS) has provided limited oversight of the 340B and Medicaid Drug Rebate Programs,...more

K&L Gates Triage: 340B Update: CMS Issues Guidance for Avoiding Duplicate Discounts in Medicaid

K&L Gates LLP on 1/30/2020

In this episode, Macy Flinchum and Victoria Hamscho discuss recent developments in the 340B Drug Pricing Program, including recent guidance by the Centers for Medicare and Medicaid Services on best practices for states to...more

2020 Starts Off with Two Government Publications Critical of 340B Program Oversight

McDermott Will & Emery on 1/14/2020

Less than two weeks into the new year, the federal government has released two new publications addressing concerns related to 340B Program oversight by both state and federal agencies. After a relatively quiet 2019, 340B...more

State Medicaid Programs and 340B: 50-State Survey Results

Manatt, Phelps & Phillips, LLP on 10/23/2019

Editor’s Note: To help provide clarity on the interplay between Medicaid and 340B, Manatt Health has developed a 50-state survey on 340B, analyzing how state Medicaid programs reimburse 340B-covered entities and contract...more

K&L Gates Triage: 340B Program: A Conversation with Chris Hatwig, Apexus President Part 3

K&L Gates LLP on 12/20/2018

This is the final episode in K&L Gates’ three-part series on the 340B Program with Chris Hatwig, President of Apexus, LLC. Apexus serves as HRSA’s Prime Vendor under the 340B Program, including by providing technical...more

340B Update: HRSA Accelerates Implementation of Long-Delayed 340B Pricing and Manufacturer Penalties Rule

K&L Gates LLP on 11/5/2018

On October 31, 2018, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) released a notice of proposed rulemaking (“NPRM”) which proposes to move up the...more

K&L Gates Triage: 340B Update: State Medicaid 340B Billing Requirements

K&L Gates LLP on 4/25/2018

In the midst of the ongoing federal conversation surrounding the 340B Drug Pricing Program, individual states are implementing a number of regulatory efforts related to the 340B Program at an increasingly fast pace. These...more

The Proposed 340B Guidance: Who is the Biggest Loser?

Mintz - Health Care Viewpoints on 10/8/2015

We have now had more than 30 days to digest HRSA’s proposed 340B Drug Pricing Program Omnibus Guidance (“Proposed Guidance”), intended to clarify expectations and provide guidance on key issues in the 340B Program. There are...more

Health Law Pulse - October 2015

Robinson & Cole LLP on 10/8/2015

The Health Resources and Services Administration (HRSA) recently issued proposed omnibus guidance (Omnibus Guidance) interpreting various provisions of the 340B Drug Pricing Program (340B Program). The 340B Program allows...more

HHS Issues Proposed 340B Program Omnibus Guidance: Five Things to Watch

Holland & Knight LLP on 9/29/2015

The 340B Drug Pricing Program (340B Program), established by Section 602 of the Veterans Health Care Act of 1992, is administered by the Health Resources and Services Administration (HRSA) of HHS. The 340B Program requires...more

340B Guidance: Eight Key Points Covered Entities Should Consider

BakerHostetler on 9/11/2015

On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to...more

HRSA Publishes Proposed 340B Drug Pricing Program Omnibus Guidance - Comments Due to HRSA on or before Tuesday, October 27, 2015

King & Spalding on 9/8/2015

On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more

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